Wednesday, October 25, 2023
Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, has established a partnership with AbbVie Inc. to advance the Phase 3 clinical program of upadacitinib (RINVOQ®) for individuals living with systemic lupus erythematosus (SLE). In this collaboration, Lupus Therapeutics will take an active role in recruiting study participants, activating research sites, and engaging with academic centers across North America through the Lupus Clinical Investigators Network (LuCIN).
Lupus is a severe autoimmune disease with a wide range of symptoms, from debilitating fatigue to life-threatening organ damage. Regrettably, only one new treatment for SLE has been approved in the United States over the past decade. Lupus Therapeutics and the Lupus Research Alliance are deeply committed to expediting the development of potential treatments for this community in desperate need of additional therapeutic options.
Following the promising results of a Phase 2 study, AbbVie decided to advance upadacitinib's clinical program in SLE to Phase 3 earlier this year. The Phase 3 program, known as SELECT-SLE, includes two studies aimed at evaluating the effectiveness and safety of upadacitinib in the form of once-daily oral tablets compared to a placebo, in combination with standard background therapy. This is followed by a long-term extension phase. SELECT-SLE is actively recruiting individuals living with SLE and further details can be found on clinicaltrials.gov under NCT05843643.
Upadacitinib, developed by AbbVie, has received approval in the United States for use in seven immune-mediated diseases. It functions by inhibiting specific signals within the body's cells that are believed to trigger inflammation. It's essential to note that the use of upadacitinib in systemic lupus erythematosus has not been approved, and regulatory authorities have not yet evaluated its safety and efficacy.
Lupus Therapeutics, expressed, "The partnership between Lupus Therapeutics and AbbVie will leverage the expertise of clinical researchers in the Lupus Clinical Investigators Network to facilitate and enhance the clinical trial process for evaluating upadacitinib in SLE. Our goal is to expedite the development of much-needed potential treatment options for SLE, thereby enhancing the quality of life for people living with lupus.
Lupus is a chronic and intricate autoimmune disease that affects millions of individuals worldwide. It predominantly impacts women, with more than 90 percent of cases occurring during their childbearing years, typically between the ages of 15 and 45. Ethnic minorities, such as Blacks/African Americans, Hispanics, Asians, and Native Americans, face a significantly higher risk—two to three times greater—of developing lupus compared to Caucasians. In lupus, the immune system, which is designed to protect against infections, produces antibodies that mistakenly identify the body's cells as foreign invaders, leading other immune cells to attack and potentially harm vital organs like the kidneys, brain, heart, lungs, blood, skin, and joints.